Job Title:
Drug Safety Physician
Job Reference: JR134262
Locations: Chennai, Trivandrum
Department: Physician / Pharmacovigilance
Employment Type: Full-time
Hiring Manager: Archana Bakkiyarajan
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to driving innovation and excellence in clinical development. We foster an inclusive environment and invite you to join our mission to advance innovative treatments and therapies.
Role Overview
As a Drug Safety Physician at ICON, you will oversee medical aspects of pharmacovigilance activities, ensuring the safety of investigational drugs and supporting drug safety reporting and risk management.
Key Responsibilities
Review and accurately assess adverse events (AEs) and adverse drug reactions (ADRs) including coding (e.g., MedDRA), seriousness, expectedness, listedness, and relatedness.
Provide medical support to the Drug Information & Pharmacovigilance Product Support Center including handling queries and assessing adverse reactions.
Review aggregated safety reports such as patient profiles, line listings, IND annual reports, Annual Safety Reports, and Periodic Safety Update Reports.
Assess safety issues arising in clinical trials and post-marketing, escalate concerns, and collaborate with clients on resolution strategies.
Support and provide training on regulatory requirements for expedited and periodic reporting of AEs/ADRs.
Review and provide input on Project Specific Procedures and participate in project-related meetings.
Communicate with clients as per project requirements.
Assist with code-break activities and review clinical trial protocols, product information, and core safety documents.
Provide pharmacovigilance consultancy regarding regulatory reporting and safety information.
Guide Medical and Safety Services staff on regulatory reporting obligations.
Perform other assigned duties as required.
Candidate Profile
Qualifications:
Medical degree (MD or equivalent) with an active medical license.
Board certification or equivalent experience in a relevant medical specialty (e.g., Internal Medicine, Pharmacology).
Experience:
Prior experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry is preferred.
Skills:
Strong clinical judgment and analytical skills with the ability to interpret complex medical data.
Excellent communication and teamwork skills to collaborate effectively across multidisciplinary teams.
What ICON Can Offer You
Competitive salary with a comprehensive benefits package focused on well-being and work-life balance.
Various annual leave entitlements.
Health insurance options tailored to you and your family’s needs.
Competitive retirement planning offerings.
Access to the Global Employee Assistance Programme (LifeWorks) with 24/7 support.
Life assurance.
Flexible, country-specific benefits such as childcare vouchers, bike purchase schemes, gym discounts, subsidized travel, and health assessments.
Diversity & Inclusion
At ICON, inclusion and belonging are core to our values. We provide an accessible, discrimination-free workplace and encourage candidates from all backgrounds to apply. Reasonable accommodations are available during the application process and employment for those with disabilities or medical conditions.
Application Instructions
We encourage you to apply even if you do not meet every qualification, as you might be the right fit for this or other roles.
Current ICON employees should apply through the internal portal.
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